Givosiran Injection, for Subcutaneous Use (Givlaari™) HCPCS Code J3490: Billing Guidelines

<p style="margin:0in 0in 0.0001pt">Effective with date of service Nov. 26, 2019, the NC Medicaid and NC Health Choice programs cover givosiran injection, for subcutaneous use (Givlaari) for use in the Physician Administered Drug Program when billed with HCPCS code J3490 - Unclassified drugs.</p>

Author: GDIT (800) 688-6696

Effective with date of service Nov. 26, 2019, the NC Medicaid and NC Health Choice programs cover givosiran injection, for subcutaneous use (Givlaari) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3490 - Unclassified drugs.

Strength/Package Size(s): Injection: 189 mg/mL in a single-dose vial.

Indicated for the treatment of adults with acute hepatic porphyria (AHP).

Recommended Dose: 2.5 mg/kg once monthly by subcutaneous injection. See full prescribing information for further detail.

For Medicaid and NC Health Choice Billing

  • The ICD-10-CM diagnosis code(s) required for billing is/are:  
    • E80.20 - Unspecified porphyria; 
    • E80.21 - Acute intermittent (hepatic) porphyria; 
    • E80.29 - Other porphyria
  • Providers must bill with HCPCS code: J3490 - Unclassified drugs
  • One Medicaid and NC Health Choice unit of coverage is: 1 mg 
  • The maximum reimbursement rate per unit is: $222.86
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDC is: 71336-1001-01 
  • The NDC units should be reported as “UN1.”
  • For additional information, refer to the January 2012 Medicaid Special Bulletin National Drug Code Implementation Update.
  • For additional information regarding NDC claim requirements related to the PADP, refer to the PADP Clinical Coverage Policy 1B, Attachment A, H.7 on Medicaid's website.
  • Providers shall bill their usual and customary charge for non-340B drugs.
  • PADP reimburses for drugs billed for Medicaid and NC Health Choice beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the “UD” modifier on the drug detail.
  • The fee schedule for the PADP is available on Medicaid's PADP web page.

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